Regulatory Affairs Registration Manager - Belgium
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Posted on : 15 April 2017
- We are looking for a Regulatory Affairs Registration Manager in Pharmaceuticals sector, being responsible for the maintenance of the worldwide product licences.
- The RA Registration Manager will ensure the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests etc …
Primary Tasks & Responsibilities:
- Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
- Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fulfilled
- Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
- Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
- Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met
- Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved
- Ensure the tracking of relevant correspondence with Authorities and Local Operating Companies (LOCs) in archiving database (TRAC-IT)
- Communicate with external regulators on specific enquiries
- Communicate regulatory updated information to internal stakeholders
- Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately.
- Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
- Be responsible for Product Registration activities of one or several projects
- Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions.
- University degree (preferably biological/chemical)
- Ideally more than 2 years experience in the pharmaceutical industry including 1 year RA experience.
- Knowledge of Regulatory legislation in at least one geographic area
- Basic understanding of biologicals
- Fluent in English; French is an asset
- MS Office suite (Word, Excel, PPT)
Soft skills :
- Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
- Analytical capacity
- Good organizational skills
- Flexible work approach; enjoys a varied working day
- Teamwork and collaboration
- Customer oriented
- Can work under stress and to deadlines
- An eye for detail
What We offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
Our company is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.